Project Manager, Clinical Science (Remote) - Neurovascular (R452309)
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
We are currently seeking a Project Manager, Clinical Science to join our Neurovascular Division to be based in Freemont, CA or remotely anywhere in the United States.
Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business provides innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.
WHO WE WANT:
• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
The Project Manager, Clinical Science, is responsible for the facilitation and initial implementation of the clinical trial strategy for Stryker Neurovascular (NV). The mission will be to develop and evolve a program designed to create strategy and manage the process for Stryker Sponsored clinical evidence generation to fulfil regulatory requirements, support educational needs, and provide data driven solutions for complex and multi-dimensional roadmaps requiring clinical evidence. This global role will have a unique opportunity to work with various clinical and regulatory functions on large- and small-scale clinical programs, including those in support of PMA, HDE, 510(k), and MDR submissions.
WHAT YOU WILL DO:
Manage and align all aspects of Clinical Affairs, HCPs, R&D , RA, Marketing, and other Customer Excellence functions to support global clinical science and strategy needs. Facilitate conversations, work through conflict, and drive decision making at the initial study design and key amendments across entire NV lifecycle and portfolio
Develop an integrated clinical science plan (e.g., “Playbook”) with input from key clinical and cross functional stakeholders
Develop clinical protocol synopsis and work with program managers to turn this into a fully developed protocol
Work with other clinical partners to consider the impacts of evidence generation (including Stryker run clinical trials, Investigator Initiated studies and pre-clinical work) and podium and publication activities within the trial strategy, to include both preclinical and clinical evidence
Work closely with all Clinical stakeholders to drive efficiency and best practices within the NV division to optimize investments in clinical data collection
Collaborate with peers in other Stryker divisions, as well as those inside/outside industry, to further drive innovation, knowledge, technological enhancements, and best practices
Translate the strategic plan and vision of NV Clinical Affairs for the generation and delivery of high quality, scientifically robust evidence along the product lifecycle on time and on budget and that supports the needs of cross-functional stakeholders
Work closely with technical and operational leadership to use data and analytics to measure quality, efficiencies, and process-related outcomes and to assess the impact of various clinical and programmatic interventions
Establish and maintain strong professional relationships with key external stakeholders (medical experts, medical societies, patient advocacy groups, and clinical/medical stakeholders.)
Conduct bibliographic and regulatory database searches, as well as Internet-based research, and prepare ad hoc reports.
Assess real world data assets and maintain a portfolio of sources, including data licenses, and access to data platforms and tools
Convey health outcome-based information for products in the NV portfolio to executive decision-makers, external scientific experts, and relevant business influencers to inform market access and reimbursement decisions
Drive value added efficiency and automation across the department
Participate in PDP Meetings as clinical functional representative
WHAT YOU NEED:
Bachelor’s Degree required; in a health/science-related field preferred.
A Master’s or Ph.D. degree in health/science-related field preferred.
6+ years of combined experience in clinical research, clinical trials, or healthcare industry required.
2+ years Project Management experience – required.
Previous medical device, pharma or biotechnology experience required.
Experience developing and maintaining department Standard Operating Procedures (SOPs) required.
Expert knowledge of governmental regulations and international standards relating to GCP/GLP,
Strong analytical business acumen capabilities.
Determined, persistent and excellent influencing skills
Demonstrated experience in establishing programs or initiatives that resulted in positive change
Excellent collaboration and communication skills; strong cross-functional influencing skills; global teamwork and cultural awareness.
Experience working in or cross functional team projects. Experience leading cross functional core team projects a plus.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.